The present application relates to the field of isotope analysis and, in particular, an emerging new field of analytical chemistry that is directed to the derivation of information regarding the origins of synthetic products from processes in which the amounts or ratios of isotopes in either synthetic starting materials, intermediates or products are traced.
The stable isotopic composition of matter is a way to differentiate one material from another when the materials have the same elemental composition. In the pharmaceutical industry, there is a need to trace precursors (i.e., starting materials and/or synthetic intermediates) through the manufacturing process, through the marketplace, and into various usages. Products such as active pharmaceutical ingredients (APIs), excipients of drug products, synthetic intermediates, impurities in drug products, raw materials and drug products are among those products which a pharmaceutical manufacturer may wish to trace. The ready identification of products and chemical processes would allow a pharmaceutical manufacturer to monitor its products for quality purposes as well as to act as an impediment against fraudulent “knock-offs” or counterfeits. Product tracing and identification is also desirable with regard to other types of products, such as, for example, combustible fuel, environmental analytes, foods, explosive and ammunition and paint.
There is also a need for new techniques directed to “pharmaceutical authenticity” or “pharmaceutical security,” such as, for example, new techniques for investigating a suspect sample of undefined origin in furtherance of drug counterfeiting investigations and/or process patent infringement investigations. Manufacturers and regulatory authorities are confronting pharmaceutical security using multiple diverse tools, which can be categorized as overt techniques, covert techniques or forensic (analytical) techniques, the latter of which has only recently begun to receive significant attention. Purposeful misidentification of pharmaceutical materials threatens the efficacy of intermediates and end-products, consumer confidence, and the economic well-being of pharmaceutical manufacturers. Thus, pharmaceutical manufacturers and regulatory agencies have a strong interest in ensuring product authenticity and security. The main areas of concern associated with purposeful misidentification are counterfeiting, diversion (also known as countertrading), vicarious liability, theft, and patent infringement.
It is apparent from the above that there is a continuing need for advancements in the relevant field, including new methods and systems for identifying and distinguishing products and processes by which they are made. The present application provides such an advancement and provides a variety of additional benefits.